Cardiospy ECG Holter System

The battery powered Cardiospy ECG Holter System provides 1, 2, 3 and 12 channel recordings, depending on the recorder and patient cable type being used. The Cardiospy ECG Holter System…

Registry build 21.09.26

The battery powered Cardiospy ECG Holter System provides 1, 2, 3 and 12 channel recordings, depending on the recorder and patient cable type being used. The Cardiospy ECG Holter System includes a recorder, an USB dongle (for bluetooth communication) and the Cardiospy software. The Class II medical device is intended to acquire, record and store up to 24, 48, 72 hours and 1 week of ECG data of patients that have been connected to the recorder and are undergoing Holter monitoring and to support the medical staff in analyzing and deciding the proper and adequate diagnosis. The cardiac data and analysis provided by Cardiospy ECG Holter System will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns. The universal analysis SW provides full disclosure ECG recordings on channels with a precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis with color coded display and printing with interactive modification possibilities in the automatic analysis in several languages. Export-import and archiving option of the recordings is available. The evaluation software works with a conventional PC- based computer under Win 2000/XP/VISTA , Windows 7, Windows 8, Windows 10 operating systems. The connection between the Holter and computer is performed by using Bluetooth and USB dongle. The Cardiospy analysis software provides ECG records of excellent quality.

2manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

Concentrated in Hebei (1), Shanghai (1).

Chinese manufacturers registered for FDA product code MLO
Manufacturer City Province Registered as Device types
Contec Medical Systems Co., Ltd. Qinhuangdao Hebei Manufacturer 22
Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC Shanghai Shanghai Specification developer 6

Record

Regulatory record for Cardiospy ECG Holter System
Listed by Labtech Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság
FDA product code MLO
Device type Electrocardiograph, Ambulatory, With Analysis Algorithm
Device class Class 2
Regulation 21 CFR 870.2800
510(k) K140847
Record published 2017-12-06
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries manufacturing date, serial number
Sizes Width 18.5 to 53 mm; weight 50 g; length 67.5 mm

Catalogue Numbers

Catalogue numbers for Cardiospy ECG Holter System
Catalogue number Size Status
USB-02 Dongle Weight 50 g In distribution
EC-2H Length 67.5 mm In distribution
EC-12H Length 67.5 mm In distribution
EC-3H Weight 50 g In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
HScribe Mortara Instrument, Inc. 55
Welch Allyn, Inc. Welch Allyn, Inc. 41
Millennia Software Braemar Manufacturing, LLC 18
Patient Cable Global Instrumentation, LLC 13
Modality Manager Mortara Instrument, Inc. 10
Norav 1200 Series PC-ECG Norav Medical Inc. 6
Matrix Holter System Global Instrumentation, LLC 5
GI Holter System Global Instrumentation, LLC 5
WA Holter System Global Instrumentation, LLC 3
Contec Contec Medical Systems Co., Ltd. 3
Scribe Mortara Instrument, Inc. 2
Pouch Global Instrumentation, LLC 2

Showing 12 of 33. All products under Electrocardiograph, Ambulatory, With Analysis Algorithm

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer